TBD 36026182

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-09-05 for TBD 36026182 manufactured by Unomedical Zavodskaya Street 50.

MAUDE Entry Details

Report Number3007966929-2019-00326
MDR Report Key8966225
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-09-05
Date of Event2019-08-05
Date Mfgr Received2019-08-13
Date Added to Maude2019-09-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1UNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer StreetFE UNOMEDICAL LTD MINSK REGION
Manufacturer CityMINSKAYA VOBLASTS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTBD
Generic NameCATHETER AND TIP, SUCTION
Product CodeJOL
Date Received2019-09-05
Model Number36026182
Lot Number318774
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer AddressFE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-05

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